# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division (ii): Each micro-organism that is subject to the application shall be identified and named at the species level. The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated.

Extent: E+W+S+N.I.

It must be indicated whether the micro-organism:
is indigenous or non-indigenous at the species level to the intended area of application,
is a wild type,
is a spontaneous or induced mutant,
has been modified, using techniques described in Part 2 of Annex IA and in Annex IB to Directive 2001/18/EC of the European Parliament and of the Council.
In the latter two cases, all known differences between the modified micro-organism and the parent wild strain must be provided.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/1/division/1.3/division/ii (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-1/division-1.3/division-ii
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.